HLA-mismatched micro-transplantation after induction chemotherapy
OtherHLA-mismatched micro-transplantation after induction chemotherapy
NCT Number: NCT03439371
This study aims at evaluating the safety and the tolerance of the micro-transplantation in elderly patients with acute myeloid leukemia who are ineligible to conventional allogeneic transplantation.
Interested in participating?
Request Info60 year–75 year
All sexes
Interventional
Not applicable
CHU Estaing, Clermont-Ferrand, France
Acute Myeloid Leukemia (AML) is an aggressive hematological malignancy with a median age at diagnosis of 65 years. Outcomes of AML in elderly population remain unsatisfactory with low rates of complete remission, poor disease-free and overall survival. Therapeutic management of older patients with AML deals with patient-related features (i.e. comorbid conditions and performance status) as well as disease-related prognostic factors (i.e. cytogenetics and molecular genetics). Even if allogeneic hematopoietic-cell transplantation provides the strongest antineoplasic effect, this treatment option remains limited for older patients owing to toxicities, the development of significant graft-versus-host disease (GVHD) and logistics of donor availability. More recently, micro-transplantation has emerged as an alternative strategy based on the infusion of mobilized HLA-mismatched related donor cells after induction chemotherapy, thus exerting a graft-versus-leukemia effect without substantial donor engraftment and GVHD. Therefore, there is much of interest in investigating the efficacy and the safety of this method for older patients with AML who are not candidates for allogeneic stem cell transplantation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
HLA-mismatched micro-transplantation after induction chemotherapy
Time frame: 2 years
Rate of overall survival will be reported.
Time frame: 3 months
Number of platelets will be reported.
Time frame: 3 months
Number of neutrophils will be reported.
Time frame: 3 months
Percentage of leukaemic blasts will be reported.
Time frame: 2 years
Rate of complete remission :
Time frame: 2 years
Presence of graft versus host disease will be reported.
Time frame: 2 years
Median overall survival will be calculated.
Time frame: 2 years
Median progression-free survival will be calculated.
Time frame: 3 months
Presence of microchimerism will be reported.
Contact information is provided by the study sponsor or research team.
Elisabeth Daguenet, PhD
CONTACT
04 77 91 70 89 ext. +33
Jérôme Cornillon, MD
CONTACT
04 77 91 67 26 ext. +33
Centre Hospitalier Universitaire de Saint Etienne
Other
A Phase II, Multicenter, Open Label Study Evaluating the Efficacy and the Tolerance of Micro-transplantation in Elderly Patients With Acute Myeloid Leukemia (MTSA)
Acronym: MTSA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05554406
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Birmingham, Alabama, United States
View Trial DetailsNCT06317649
Acute Myeloid Leukemia, Hematologic Diseases
Birmingham, Alabama, United States
View Trial DetailsNCT07306832
Acute Myeloid Leukemia, Disease Attributes
Palo Alto, California, United States
View Trial DetailsNCT06672146
Acute Myeloid Leukemia, Hematologic Diseases
Tucson, Arizona, United States
View Trial Details